Superion® InterSpinous Spacer

Superion? InterSpinous Spacer

Caution: Federal Law restricts this device to sale by or on the order of a physician. This brochure will provide you with information about the Superion? InterSpinous Spacer, a new treatment for moderate lumbar spinal stenosis. Your doctor will answer any questions you have regarding moderate lumbar spinal stenosis and the Superion? Spacer as a treatment for you.

Vertiflex? 1351 Calle Avanzado, Suite 100

San Clemente, CA 92673 (949) 940-1400

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Table of Contents

WHAT IS THE SUPERION? SPACER? .................................................................................. 3 ARE YOU A CANDIDATE FOR THE SUPERION? PROCEDURE? ................................. 5 WHO SHOULD NOT HAVE THE SUPERION? SPACER? (CONTRAINDICATIONS) . 6 WHAT WARNINGS SHOULD I KNOW ABOUT WHEN THE SUPERION? SPACER IS USED? ............................................................................................................................................ 7 WHAT ARE PRECAUTIONS FOR THE USE OF THE SUPERION? SPACER? ............. 7 WHAT PROBLEMS MAY HAPPEN FROM SUPERION? SURGERY? (RISKS) ............ 9 HOW HAVE WE TESTED THE SUPERION? SPACER IN CLINICAL TRIALS?........ 12 WHAT CAN I EXPECT DURING MY SUPERION? SPACER SURGERY? ................... 13 WHAT CAN I EXPECT AFTER MY SUPERION? SPACER SURGERY? ...................... 14 WHEN SHOULD I CALL MY DOCTOR? ............................................................................. 15 WHERE CAN I FIND OUT MORE INFORMATION? ........................................................ 15 MORE ABOUT YOUR CONDITION...................................................................................... 15 HOW DO I KNOW IF I HAVE SPINAL STENOSIS? .......................................................... 18 SUMMARY ................................................................................................................................. 19

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INTRODUCTION Now that you have completed at least 6 months of nonsurgical treatment with no relief from your moderate lumbar spinal stenosis symptoms, your doctor has reviewed your medical history, xrays, and other tests. Your doctor has advised that you should consider surgery to relieve your leg pain. This brochure can help you make a better choice on how to treat your pain.

WHAT IS THE SUPERION? SPACER? One surgical option your doctor may offer is the Superion? InterSpinous Spacer (Superion? Spacer). The Superion? Spacer (please see Figure 1 below) is made of a mixture of metal elements (titanium alloy). This implant fits between the bones (spinous processes) in your lower back. These are the bony structures located in the back of the spine. These bones can be felt by placing your fingers down the center of the back. The Superion? Spacer may help relieve your symptoms by limiting movement of your spine that may be causing your symptoms. This may help reduce the pain in your back, groin, or legs. Devices made from metal mixture (alloy) are often used in bone procedures in the body.

Figure 1: The completely open (deployed) Superion? Spacer viewed from above. (A 10? coin is shown for scale.) The implant fits between the bones (spinous processes) and the wings are designed to keep the implant

from moving.

A clinical study evaluated the Superion? Spacer. The study was done in thirty-one (31) hospitals across the United States. 391 patients were in the study. Some patients got the Superion? Spacer. The rest of the patients got the control device. The control device is FDA approved. You will learn more about this study in the rest of this brochure.

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Once placed, the Superion? Spacer rests between two bones (spinous processes), as shown below in Figures 2 and 3.

Vertebral Body

Superion? Spacer Spinous Process

Intervertebral Disc

Figure 2: Superion? Spacer shown implanted in the spine viewed from the right side

Superion? Spacer

Spinous Processes

Figure 3: Superion? Spacer shown implanted in the spine viewed from the back

WHAT IS SPINAL STENOSIS? Spinal stenosis is a narrowing of the passageways in the spine. These passageways contain the spinal cord and nerve roots. This narrowing can be caused by a few things. These include thickening of tissue (ligaments) that connects two bones, bulging of discs between the bones, or overgrowth of bone. The spinal cord and the nerve roots that exit the spinal canal can become pinched. This can cause pain, numbness, tingling and/or weakness in the back and legs. This

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pain is usually more noticeable when you walk. This pain is lessened when you bend forward or sit. Refer to Page 12 of this brochure for additional information about spinal stenosis.

WHAT ARE MY TREATMENT OPTIONS? There are ways to treat your moderate lumbar spinal stenosis. Some are:

? Non-surgical ways o Your doctor can inject you with a drug (steroids) to lower swelling and treat pain in your hips or down the leg. Pain relief from this treatment may not last long. You should not have more than three injections in a six month time. o You can rest and reduce your activity level. o You can take physical therapy and exercise. o You may be prescribed pain medications.

? Surgical ways o Decompression surgery only. This surgery removes the bone and other tissues around your nerves causing the pain. This surgery helps relieve pressure on your spinal cord and nerves. o Implantation of a device that goes between the bones in your back (spinous processes) like Superion? or other commercially available interspinous distraction devices. No surgical decompression is used in this surgery. o Decompression surgery with spinal fusion. In spinal fusion, decompression surgery is first performed to remove the bone and tissue that is causing the pain. Your doctor then puts some of your bone (bone graft) between two bones (usually vertebrae) in the area of the decompression surgery. The bone graft is usually either spinal bone removed during the decompression surgery or bone from your hip removed through a separate cut. The purpose of the bone graft is to cause new bone to grow between the two bones to "fuse" them. This is supposed to stop motion in that portion of the spine that may be contributing to your symptoms. Your doctor also uses screws and rods to hold the bones in place. The rods and screws are usually left in your spine unless a problem happens later. If a problem happens with the rods and screws, they are removed or replaced surgically.

Discuss your options with your doctor and select the treatment method that best seems to meet your current pain level and lifestyle.

ARE YOU A CANDIDATE FOR THE SUPERION? PROCEDURE? To be a candidate for treatment with the Superion? Spacer:

? You must have pain, numbness, and/or cramping in the legs related to moderate lumbar spinal stenosis in your lower back. One sign of having spinal stenosis is that it is hard to walk a long way, such as ? mile, without symptoms. Another sign is pain in your lower

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